Study Evaluating Effects of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG in Healthy Subjects

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy; Adult

Treatments: Other: placebo; Drug: SAM-531; Drug: Donepezil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519298

3193A1-1110

Details and patient eligibility

About

Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in healthy subjects.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men or women of non-childbearing potential aged 18 to 50 years inclusive on study day 1.
• Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg.
• Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital sign measurements, and 12-lead electrocardiogram.

Exclusion criteria

• Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, hematologic, neurologic, or psychiatric disease.
• Clinically significant abnormal standard EEG at screening.
• Consumption of any caffeine-containing products or alcoholic beverages within 48 hours before study day 1.

Trial design

25 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: SAM-531

2

Placebo Comparator group

Treatment:

Other: placebo

3

Active Comparator group

Treatment:

Drug: Donepezil